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市場調査レポート

生物医薬品無菌製剤 (フィル・アンド・フィニッシュ) :ベストプラクティス調査 2015年

Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015

発行 HighTech Business Decisions, Inc. 商品コード 261635
出版日 ページ情報 英文 550 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=105.42円で換算しております。
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生物医薬品無菌製剤 (フィル・アンド・フィニッシュ) :ベストプラクティス調査 2015年 Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015
出版日: 2015年11月30日 ページ情報: 英文 550 Pages
概要

生物医薬品無菌製剤 (フィル・アンド・フィニッシュ) 契約サービス市場は過去3年間に複利年率17%で成長しました。同市場は今後も引き続き拡大し、2020年には24億米ドルに達すると予測されています。

当レポートでは、生物製剤の無菌製剤製造受託市場について調査分析し、バイオマニュファクチャリング、アウトソーシングに関する現在の戦略、必要なサービス、能力、価格政策、将来的戦略などをまとめ、ユーザーおよびサプライヤーに関する詳細なデータとともにお届けいたします。

第1章 エグゼクティブサマリー

第2章 調査方法、定義、略語

第3章 無菌製剤 (フィル・アンド・フィニッシュ) 製造受託:市場概要

  • イントロダクション
  • サプライヤー:無菌製剤製造受託企業
    • 企業の種類
    • 製造受託企業
    • 投薬形態とサービス
    • 製造受託の能力
  • 顧客:製薬会社、バイオテクノロジー会社
    • 顧客の製品
    • アウトソースされるフィル・アンド・フィニッシュ:投薬形態別
    • 顧客の将来のアウトソーシング見込み
    • アウトソーシングのニーズ
  • 市場の能力
  • 市場規模
    • 顧客支出に基づく市場規模予測
    • 製造受託企業の収益に基づく市場規模予測
    • 投薬形態・サービス分類別の市場規模
  • 市場成長予測
  • 無菌製剤製造受託市場の動向
    • 産業革新と課題
    • 産業全体の動向

第4章 製薬会社・バイオテクノロジー会社:クライアント分析

  • イントロダクション
  • 製造需要
    • ニーズ
    • 投薬形態
    • 臨床・商業製品
  • 製造技術
    • 薬剤発売の計画フォーマット
    • 新しいデリバリー技術
    • 特殊取り扱い要件
    • 収率損失
  • アウトソーシング戦略
    • 現在の社内製造能力・アウトソーシング戦略
    • 社内製造能力の変化
    • 中核/非中核技術の影響
    • 標準/非標準技術の影響
    • 今後5年間の製造アウトソーシングへのフォーカス
  • アウトソーシングのニーズ
    • アウトソースサービス
    • フィル・アンド・フィニッシュCMOによって十分なサービスを受けていない領域
    • フィル・アンド・フィニッシュCMOが緩和できる主な課題
  • 受託機関の選定
  • 契約価格
    • 料金モデル
    • 料金構造:技術移転費用
    • 料金構造:予約料
    • 料金構造:取消料
  • アウトソース費
    • 無菌製剤 (フィル・アンド・フィニッシュ) CMOへの支払い価格
    • アウトソーシング予算
    • アウトソーシング予算:サービスカテゴリー別
  • 受託機関との関係
    • 受託パートナーの特定
    • 好まれる受託機関
    • 期待に応える受託機関の主な懸念
    • 保証、保障、補償
    • ク理想の製造ネットワークもしくはアライアンス構造
  • 将来の動向と見込み
    • 規制要件の変化
    • 将来の無菌製剤の課題と障害
    • 将来の技術・オペレーション動向
    • 無菌製剤に影響を与える新しい製品・革新
    • 生物医薬品無菌製剤の将来の動向

第5章 受託製造業者

  • イントロダクション
  • 能力
  • 製造活動
  • 製造業務
  • 製造技術
  • 価格
  • 顧客との関係
  • 無菌製剤産業の収益と成長
  • 製造上の課題・将来の動向

付録A-D

図表

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目次

The market for biopharmaceutical contract fill-and-finish services has grown at a compound annual rate of 17% over the past three years. This market will continue to expand and reach $2.4 billion in 2020 according to HighTech Business Decisions latest report, “Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015.” On average, executives from contract manufacturing organizations expect future annual market growth of 15% per year. Driving this growth for fill-and-finish services is demand for biotechnology drugs, investment in biotechnology projects, and new service offerings. The biotechnology industry continues to rely on fill-and-finish contract manufacturing organizations to provide filling and lyophilization capacity for both its commercial- and clinical-phase drug product production.

“Over the past few years we have seen strong industry growth for outsource filland- finish services for biopharmaceuticals,” said William Downey, president of HighTech Business Decisions. “The biopharmaceutical fill-and-finish contract manufacturing organizations continue to show strong optimism about the demand for their services. On a technical side, the use of prefilled syringes continues to expand, and there continues to be strong interest in needle-free technologies. From a strategic perspective, we expect to see more industry consolidations over the next few years, new market entrants, and greater in-house fill capacity. As a result of these trends, we expect industry capacity utilization rates will remain flat.”

HighTech Business Decisions just published the results of its study in “Biopharmaceutical Contract Fill-and-Finish: Best Practices Study 2015.” The findings are based on in-depth interviews and inputs from leading pharmaceutical and biotechnology companies and contract manufacturing organizations. This 550- page industry report with over 200 summary data tables and charts analyzes both the commercial and technical factors affecting this industry. The report covers current and future market size, manufacturing technologies, client outsourcing plans, contract outsource capacity, pricing, commercial terms and practices, underserved market segments, and future industry trends.

Table of Contents

Chapter 1: EXECUTIVE SUMMARY

  • 1.1. Introduction
  • 1.2. Market Overview
    • 1.2.1. Introduction
    • 1.2.2. Industry Drivers
    • 1.2.3. Market Size
  • 1.3. Summary of Customer Needs
    • 1.3.1. Products
    • 1.3.2. Outsourcing Strategies
    • 1.3.3. Outsourcing Budgets
  • 1.4. Summary of Fill-and-Finish Contractors' Capabilities
    • 1.4.1. Dosage Forms
    • 1.4.2. Capacity Increases
    • 1.4.3. Industry and Company Growth Rates
    • 1.4.4. Contracting Business by Product Type
  • 1.5. Industry Trends and Observations

Chapter 2: METHODOLOGY, DEFINITIONS, AND ACRONYMS

  • 2.1. Research Objectives
  • 2.2. Research Methodology
  • 2.3. Definition of Parenteral Fill-and-Finish Manufacturing
  • 2.4. Box-and-Whiskers Plot Definition
  • 2.5. Acronyms

Chapter 3: FILL-AND-FINISH CONTRACT MANUFACTURING: MARKET OVERVIEW

  • 3.1. Introduction
  • 3.2. Suppliers: The Fill-and-Finish Contract Manufacturers
    • 3.2.1. Types of Fill-and-Finish Contract Companies
    • 3.2.2. Fill-and-Finish Contract Manufacturing Companies
    • 3.2.3. Dosage Forms and Services
    • 3.2.4. Fill-and-Finish Contract Manufacturing Organizations' Capacities

Chapter 3: 3.3 The Customers: Pharmaceutical and Biotechnology Companies

  • 3.3.1. Customers' Products
  • 3.3.2. Outsourced Fill-and-Finish by Dosage Form
  • 3.3.3. Customers' Future Outsourcing Expectations
  • 3.3.4. Outsourcing Needs
  • 3.4. Market Capacity
  • 3.5. Market Size
    • 3.5.1. Estimates of Market Size Based on Customer Spending
    • 3.5.2. Estimates of Market Size Based on Contractor Revenues
    • 3.5.3. Market Size by Dosage Form and Service Categories
  • 3.6. Market Growth Forecasts
  • 3.7. Trends in the Fill-and-Finish Contract Manufacturing Market
    • 3.7.1. Industry Opportunities and Challenges
    • 3.7.2. Overall Industry Trends

Chapter 4: PHARMACEUTICAL AND BIOTECHNOLOGY COMPANIES: CLIENT ANALYSIS

  • 4.1. Introduction
    • 4.1.1. Respondent Titles and Location
    • 4.1.2. In-House Manufacturing Sites
    • 4.1.3. Recombinant Large-Molecule Drug Products on Market
  • 4.2. Manufacturing Demand
    • 4.2.1. Manufacturing Needs
    • 4.2.2. Dosage Forms
    • 4.2.3. Clinical and Commercial Products
  • 4.3. Manufacturing Technologies
    • 4.3.1. Planned Format for Drug Launch
    • 4.3.2. New Delivery Technologies
    • 4.3.3. Special Handling Requirements
    • 4.3.4. Yield Loss

Chapter 4: 4.4 Outsourcing Strategies

  • 4.4.1. Current In-House Filling Capacity and Outsourcing Strategy
  • 4.4.2. Changes to In-House Filling Capacity
  • 4.4.3. Impact of Core/Non-Core Technology
  • 4.4.4. Impact of Standard/Non-Standard Technology
  • 4.4.5. Focus of Filling Outsourcing over Next 5 Years
  • 4.5. Outsourcing Needs
    • 4.5.1. Outsourced Services
    • 4.5.2. Areas Underserved by Fill-and-Finish CMOs
    • 4.5.3. Key Challenges a Fill-and-Finish CMO Can Help Alleviate
  • 4.6. Contractor Selection
    • 4.6.1. Essential Characteristics Sought in a F&F Contractor
    • 4.6.2. Key Components for Successful Collaboration with a Fill-and-Finish CMO
    • 4.6.3. Regional Outsourcing Preference
    • 4.6.4. Opinion of Emerging Market CMOs
  • 4.7. Contractor Pricing
    • 4.7.1. Price Models Used
    • 4.7.2. Fee Structure: Technology Transfer
    • 4.7.3. Fee Structure: Reservation
    • 4.7.4. Fee Structure: Cancelation
  • 4.8. Outsourced Spending
    • 4.8.1. Prices Paid to Fill-and-Finish CMOs
    • 4.8.2. Outsourcing Budgets
    • 4.8.3. Outsourcing Budgets by Service Category
  • 4.9. Contractor Relationships
    • 4.9.1. Identifying Contract Partners
    • 4.9.2. Preferred Contractors
    • 4.9.3. Top Concerns of Contractors Meeting Expectations
    • 4.9.4. Warranties, Guarantees and Indemnifications
    • 4.9.5. Ideal Production Network or Alliance Structure
  • 4.10. Future Trends and Expectations
    • 4.10.1. Regulatory Requirement Challenges
    • 4.10.2. Future F&F Manufacturing Challenges and Bottlenecks
    • 4.10.3. Future Technology and Operational Trends
    • 4.10.4. Future Trends in Biopharmaceutical Fill-and-Finish Contract Manufacturing

Chapter 5: FILL-AND-FINISH CONTRACT MANUFACTURERS

  • 5.1. Introduction
    • 5.1.1. Respondents' Titles and Experience
    • 5.1.2. Company Locations
    • 5.1.3. Regulatory Approval Status
    • 5.1.4. One-Stop-Shop CMO Model
  • 5.2. Capacity
    • 5.2.1. Dosage Forms
    • 5.2.2. Current Capacity for Fill-and-Finish
    • 5.2.3. Current Capacity for Lyophilization
    • 5.2.4. Capacity Expansions
  • 5.3. Manufacturing Practices
    • 5.3.1. Contracting Business by Product Type
    • 5.3.2. Current and Future Capacity Utilization
    • 5.3.3. Average Batch Size and Batches per Fill Line
    • 5.3.4. Number of Employees by Function
    • 5.3.5. Cost Reduction Plans
  • 5.4. Manufacturing Technologies
    • 5.4.1. Technology Impacts on Operations
    • 5.4.2. Average Yield Loss
    • 5.4.3. Focus of Capabilities in Next 5 Years
  • 5.5. Pricing
    • 5.5.1. Price Structures for Fill-and-Finish
    • 5.5.2. Batch Pricing
    • 5.5.3. Contractors' Technology Transfer Fees
    • 5.5.4. Contractors' Reservation Fees
    • 5.5.5. Contractors' Cancellation Fees
    • 5.5.6. Gross Profit Margin
  • 5.6. Customer Relationships
    • 5.6.1. Strengths and Weaknesses of Contract Manufacturers
    • 5.6.2. Competitive Attributes
    • 5.6.3. Warranties, Guarantees and Indemnifications
    • 5.6.4. Production Networks or Alliances
    • 5.6.5. Trade Shows

Chapter 5: 5.7 Fill-and-Finish Industry Revenues and Growth

  • 5.7.1. Opportunities for Growth in the Fill-and-Finish Industry
  • 5.7.2. Industry and Company Growth Rates
  • 5.7.3. Current and Expected Revenue Categories
  • 5.7.4. Revenues from Industry Segments
  • 5.7.5. Revenues from World Regions
  • 5.8. Challenges and Future Trends for F&F Manufacturing
    • 5.8.1. Most Significant Challenges/Threats
    • 5.8.2. Regulatory Requirement Challenges
    • 5.8.3. Potential Growth Areas
    • 5.8.4. Trends for the Future of F&F Contract Manufacturing

Appendix A: Write-Ups of Interviews with 26 Pharmaceutical and Biotechnology Company BioManufacturing Directors Worldwide, Unnamed and Edited for Confidentiality

Appendix B: Directory of Biopharmaceutical Fill-and-Finish Contract Manufacturers

Appendix C: Interview Guide for Pharmaceutical and Biotechnology Company Respondents

Appendix D: Interview Guide for Biopharmaceutical Fill-and-Finish Contract Manufacturers

LIST OF TABLES

Chapter 1

  • 1.2-1. Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry Capacity Estimate in Units
  • 1.3-1. Respondents Capacity by Segment
  • 1.3-2. Outsource Decision Criterion
  • 1.4-1. Fill Line Expansion Plans
  • 1.5-1. Industry Trends and Challenges

Chapter 2

  • 2.2-1. Market Research Steps
  • 2.5-1. Acronyms

Chapter 3

  • 3.2-1. Rating of Respondents' Fill-and-Finish Contract Manufacturers
  • 3.2-2. CMO Revenue Mix by Service Category: 2015
  • 3.2-3. Biopharmaceutical F&F Contract Manufacturing Industry Capacity Estimates in Units
  • 3.3-1. Estimates of Needs for Outsourced Volumes for the Respondent Group
  • 3.4-1. Biopharmaceutical F&F Outsourced Manufacturing Capacity Utilization
  • 3.5-1. Worldwide 2015 Market Size for Biopharmaceutical Fill-and-Finish Contract Manufacturing: Estimates Based on Customer Spending: US$
  • 3.5-2. Worldwide 2015 Market Size for Biopharmaceutical Fill-and-Finish Contract Manufacturing: Estimates Based on Contractors' Revenues: US$
  • 3.5-3. Market Size by Dosage Forms: US$
  • 3.5-4. Market Size by Service Category: US$
  • 3.7-1. Observations on Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry Trends: Manufacturing Trends

Chapter 4

  • 4.1-1. Titles of Pharmaceutical and Biotechnology Company Respondents
  • 4.1-2. Location of In-House Fill-and-Finish Manufacturing Sites
  • 4.1-3. Number of Recombinant Large-Molecule Drug Products on Market

Chapter 4

  • 4.2-1. Respondents' Current and Expected Capacity Needs for Outsourced Product - Vials (Lyophilized)
  • 4.2-2. Respondents' Current and Expected Capacity Needs for Outsourced Product - Vials (Not Lyophilized)
  • 4.2-3. Respondents' Current and Expected Capacity Needs for Outsourced Products - Syringes (Lyophilized)
  • 4.2-4. Respondents' Current and Expected Capacity Needs for Outsourced Products - Syringes (Not Lyophilized)
  • 4.2-5. Respondents' Current and Expected Capacity Needs for Outsourced Products - Cartridge (Not Lyophilized)
  • 4.2-6. Number of Outsourced Products by Phase by Year
  • 4.2-7. Average Outsourcing Percentage by Dosage Form
  • 4.2-8. Number of Biopharmaceutical Products Filled by Dosage Form
  • 4.2-9. Types of Respondents' Biopharmaceutical Products by Dosage Form
  • 4.3-1. Delivery Technologies Under Investigation
  • 4.3-2. Cause for Fill-and-Finish Yield Losses
  • 4.4-1. Respondent Capacity by Segment
  • 4.4-2. Outsource Decision Criterion - Respondents with In-House Capacity
  • 4.4-3. Outsource Decision Criterion - Respondents with No In-House Capacity
  • 4.4-4. Impact of Core Technology on Outsourcing Decision
  • 4.4-5. Focus of Fill-and-Finish Outsourcing Efforts in Next 5 Years
  • 4.5-1. Outsourcing of Fill-and-Finish Related Services
  • 4.5-2. Number of Products Currently and Planned to Outsource by Service
  • 4.5-3. Areas Underserved by Fill-and-Finish CMOs
  • 4.5-4. Challenges Fill-and-Finish CMOs can Help Alleviate
  • 4.6-1. Ranked Characteristics of a Good Service Level at F&F Contractor
  • 4.6-2. Rationale for Number ‘1' Ranked Good Service Characteristic
  • 4.6-3. Key Component for Successful Collaboration
  • 4.6-4. Regional Outsourcing Preferences
  • 4.6-5. Observations and Influences on Opinion about Emerging-Market CMOs
  • 4.7-1. Price Model Used for Fill-and-Finish Services by Respondent Type
  • 4.7-2. Average Technology Transfer Fees Paid by Dosage Form
  • 4.8-1. Price Per-Batch by Dosage Form by Product Phase
  • 4.8-2. Examples of Other Services and Material Charges
  • 4.8-3. Fill-and-Finish Outsourcing Budgets by Respondent Type: 2015, 2017, 2020
  • 4.8-4. Simple Average: Percentage of F&F Outsourcing Budget by Service
  • 4.8-5. Weighted Average: Percentage of F&F Outsourcing Budget by Service

Chapter 4

  • 4.9-1. Search Modes for Fill-and-Finish Contractors
  • 4.9-2. Rating of Respondents' Fill-and-Finish Contract Manufacturers
  • 4.9-3. Top Concerns of Fill-and-Finish Contractors Meeting Expectations
  • 4.9-4. Warranties, Guarantees and Indemnifications Negotiated by Respondents
  • 4.9-5. Proposed Models and Arrangements with a CMO
  • 4.10-1. Regulatory Requirements That Present the Greatest Challenges
  • 4.10-2. Challenges and Bottlenecks Facing Fill-and-Finish Manufacturing
  • 4.10-3. Technology Trends in Drug Presentations
  • 4.10-4. Technology Trends at CMOs
  • 4.10-5. Operational and Business Trends in Fill-and-Finish Contract Manufacturing
  • 4.10-6. Future Trends in Biopharmaceutical Fill-and-Finish Contract Manufacturing

Chapter 5

  • 5.1-1. Titles of Fill-and-Finish Contractor Respondents
  • 5.1-2. Fill-and-Finish Contractors: Headquarter Locations
  • 5.1-3. Regulatory Agency Approvals
  • 5.1-4. Relevance of Being a One-Stop-Shop
  • 5.2-1. Average Batch Size per Fill Line and Contractor
  • 5.2-2. Fill Capacity by Batch Size at Respondents' Facilities in 2015
  • 5.2-3. Lyophilizer Capacity by Shelf Space at Respondents' Facilities in 2015
  • 5.2-4. Lyophilizer Capacity by Batch Size at Respondents' Facilities in 2015
  • 5.2-5. Fill Line Expansion Plans
  • 5.2-6. Lyophilizer Expansion Plans
  • 5.3-1. Percent of Contracting Business by Product Type: 2015 and 2017
  • 5.3-2. Capacity Utilization Rate: Fill Line
  • 5.3-3. Capacity Utilization Rate: Lyophilization
  • 5.3-4. Number of Batches Ran per Fill Line
  • 5.3-5. Batch Size Ran by Fill Line
  • 5.3-6. Number of Employees by Function
  • 5.3-7. Plans to Reduce Fill-and-Finish Manufacturing Costs
  • 5.4-1. Technology Impacts on Fill-and-Finish Operations
  • 5.4-2. Sources of Product Yield Loss
  • 5.4-3. Focus of Manufacturing Capabilities
  • 5.5-1. Pricing Methods for Clinical and Commercial Phase
  • 5.5-2. Calculation Methods of Technology Transfer Fees
  • 5.5-3. Contractors' Cancellation Fees: Average Percentage of Total Project Fee
  • 5.5-4. Gross Profit Margin

Chapter 5

  • 5.6-1. Contract Manufacturers' Strengths and Weaknesses
  • 5.6-2. Contractor Competitive Advantage
  • 5.6-3. Warranties, Guarantees and Indemnifications Accepted by F&F CMOs
  • 5.6-4. Desired Arrangements with Clients
  • 5.6-5. Trade Shows Named by Fill-and-Finish Contractors
  • 5.6-6. Trade Shows for Best Quality Leads
  • 5.6-7. Trade Shows for Best Technical Information
  • 5.7-1. Opportunities for Growth in the Fill-and-Finish Industry
  • 5.7-2. Annual Growth Rates: Industry Estimate versus Company Forecast
  • 5.7-3. Revenue by Service Category: 2015
  • 5.7-4. Revenue Change Expected by Service Category: 2015 to 2017
  • 5.7-5. Customer Mix
  • 5.7-6. Geographic Mix
  • 5.8-1. Future Challenges to Business Operations
  • 5.8.2. Current Regulatory Challenges
  • 5.8.3. Potential Fill-and-Finish Manufacturing Growth Areas
  • 5.8.4. Future Technology Trends
  • 5.8.5. Future Business Trends

LIST OF FIGURES

Chapter 1

  • 1.2-A: Size of Worldwide Biopharmaceutical Fill-and-Finish Contract Manufacturing Industry in US$B
  • 1.3-A: Respondents' 82 Biopharmaceutical Products by Phase
  • 1.3-B: Number of Products Outsourced by Dosage Form: 2015-2020
  • 1.3-C: Simple Average Percentages of Expected Overall Outsourced Budget
  • 1.4-A: Dosage Forms Produced by Number of Contractor Respondents
  • 1.4-B: Percent of Fill Lines Available among Contractor Respondents for Various Dosage Forms
  • 1.4-C: Annual Growth Rates: Industry Estimate versus Company Forecast
  • 1.4-D: Percent of Contracting Business by Product Type: 2015 and 2017

Chapter 2

  • 2.4-A: Explanation of Box-and-Whiskers Plot

Chapter 3

  • 3.2-A: Dosage Forms Produced by Number of Contractor Respondents
  • 3.2-B: Percent of Fill Lines Available among Contractor Respondents for Various Dosage Forms
  • 3.3-A: Respondents' 82 Biopharmaceutical Products by Phase
  • 3.3-B: Percent of Products Outsourced: 2015
  • 3.3-C: Simple Average Percentages of Expected Overall Outsourcing Budget
  • 3.3-D: Number of Products Outsourced by Dosage Form: 2015-2020
  • 3.3-E: Estimates of Needs for Outsourced Batches for the Worldwide Industry
  • 3.6-A: Size of the Worldwide Biopharmaceutical Fill-and-Finish Contract Manufacturing Market in US$B

Chapter 4

  • 4.1-A: In-House Fill-and-Finish Manufacturing Capability
  • 4.2-A: Summation of Outsourced Units Required - Vials
  • 4.2-B: Summation of Outsourced Units Required - Syringes
  • 4.2-C: Percentage of Products Outsourced - 2015
  • 4.2-D: Number of Respondents' Products Produced by Dosage Form
  • 4.2-E: Respondents' 82 Biopharmaceutical Products by Phase
  • 4.2-F: Respondents' 82 Biopharmaceutical Products by Company Type
  • 4.3-A: Format Used for Drug Product Launch
  • 4.3-B: Investigation of New Delivery Technologies
  • 4.3-C: Needle-Based versus Needle-Free Delivery Technologies Under Investigation

Chapter 4

  • 4.3-D: Respondents' Special Handling Requirements
  • 4.3-E: Distribution of Percent of Products with Special Handling Needs
  • 4.3-F: Special Handling Needs Required
  • 4.3-G: Handling Needs for Typical Biologics
  • 4.3-H: Distribution of Average Fill-and-Finish Yield Losses
  • 4.4-A: Distribution of Respondents with In-House Capacity
  • 4.4-B: Changes to In-House Filling Capacity
  • 4.4-C: Core Technology's Impact on Outsourcing Decisions
  • 4.4-D: Standard Technology's Impact on Outsourcing Decisions
  • 4.6-A: Number ‘1' Ranked Good Service Characteristics
  • 4.6-B: Most Important Good Service Characteristics by Weighted Ranking
  • 4.6-C: Changing Opinion about Emerging-Market CMOs
  • 4.7-A: Different Price Model Used for Commercial Products
  • 4.7-B: Average Technology Transfer Fees Paid by Respondent Type
  • 4.7-C: Payment of Reservation Fee
  • 4.7-D: When Cancellation Charges are First Expected to be Incurred
  • 4.7-E: Cancellation Fees: Average Percentages of the Total Contract Fee
  • 4.8-A: Average Per-Batch Price by Clinical Phase
  • 4.8-B: Unit Price versus Batch Size: Non-Lyophilization
  • 4.8-C: Unit Price versus Batch Size: Lyophilization
  • 4.8-D: Price per Batch by SafeBridge® Level: Vials
  • 4.8-E: Price per Batch by SafeBridge® Level: Prefilled Syringes
  • 4.8-F: Average Fill-and-Finish Outsourcing Budgets by Respondent Type
  • 4.8-G: Simple Average: Percentage of F&F Outsourcing Budget by Service: 2015
  • 4.8-H: Weighted Average: Percentage of F&F Outsourcing Budget by Service 2015
  • 4.9-A: Search Modes for Fill-and-Finish CMOs
  • 4.9-B: Warranties, Guarantees and Indemnifications
  • 4.9-C: Negotiation of Contractor's Final Product Quality and Consequential Damages
  • 4.9-D: Preference for Production Networks or Alliances
  • 4.9-E: Preferred Characteristics of Production Networks or Alliances

Chapter 5

  • 5.1-A: Number of Years Fill-and-Finish Services Offered
  • 5.1-B: One-Stop-Shop CMO Model
  • 5.2-A: Dosage Forms Produced by Percent of Contractors Respondents
  • 5.2-B: Percent of Fill Lines Available among Contractor Respondents for Various Dosage Forms
  • 5.2-C: Comparison of Percent of Dosage Forms Produced by Contractor Type
  • 5.2-D: Capacity Expansion Plans
  • 5.2-E: Dosage Forms Being Added

Chapter 5

  • 5.3-A: Percent of Contracting Business by Product Type: 2015 and 2017
  • 5.3-B: Fill Line Capacity Utilization Rate
  • 5.3-C: Lyophilization Capacity Utilization Rates
  • 5.3-D: Average Number of Employees by Function
  • 5.3-E: Plans to Reduce Fill-and-Finish Manufacturing Costs
  • 5.4-A: Average Yield Loss
  • 5.5-A: Pricing Methods
  • 5.5-B: Use of Different Pricing Methods Based on Product Phase
  • 5.5-C: Dosage Form
  • 5.5-D: Batch Size
  • 5.5-E: Batch Pricing
  • 5.5-F: Technology Transfer Fee Charged
  • 5.5-G: Reservation Fee Charged
  • 5.5-H: When Cancellation Fees Are First Charged
  • 5.5-I: Average Targeted and Achieved Gross Profit Margins
  • 5.6-A: Warranties, Guarantees and Indemnifications Accepted by F&F CMOs
  • 5.6-B: Comparison of CMO and Pharma Respondents “Always” Negotiation Term
  • 5.6-C: Plans for Production Network or Alliances with Clients
  • 5.7-A: Average Annual Growth Rates: Industry Estimate versus Company Forecast
  • 5.7-B: Service Revenue by Contractor Type: 2015
  • 5.7-C: Revenue Contribution from Customer Groups by Contractor Type
  • 5.7-D: Percentage of Business from the World Regions by Contractor Type
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